MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-18 for TARGIS SYSTEM 410092-001 manufactured by Urologix, Inc.
[3985058]
Field service was contacted by a urologix tsr after he reported receiving a low pressure error approximately 10 minutes into a ctt procedure. The tsr said that the coolant bag was empty and he attempted to continue the procedure and while checking the location balloon, no water could be drawn out from the location balloon fill port. At that point, the procedure was stopped, the catheter was removed. The tsr stated that it appeared as though the location balloon had failed. The microwave power was being operated at approximately 30 watts during the procedure. The tsr said the catheter did not migrate because it was being held in position by the mds holder, so no patient injury had occurred. The catheter was changed and the ctt procedure was continuing without any additional errors.
Patient Sequence No: 1, Text Type: D, B5
[11683564]
Failure mode: failure of the location balloon distal adhesive joint, allowing the coude tip to become dislodged and the location balloon to bleed out through the coude tip and deflate. Root cause: communication between the coolant inflow and location balloon partitions of the plastic handle. During treatment, the pump forced fluid into the location balloon until it built up enough pressure to blow the distal adhesive joint. Additionally, the complaint stated that a low pressure error was generated approximately 10 minutes into the procedure. The balloon failure likely did not occur until shortly before the low pressure error occurred. At the rate that the coolant was "leaking" into the location balloon, it would have only taken 1-2 minutes from the time of the adhesive joint failure for the fluid to drain out of the system (thus generating the low pressure error. )
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2133936-2014-00001 |
| MDR Report Key | 3632981 |
| Report Source | 07 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-18 |
| Date of Event | 2014-01-22 |
| Date Mfgr Received | 2014-01-22 |
| Device Manufacturer Date | 2013-08-15 |
| Date Added to Maude | 2014-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. HOPE PRZYBILLA |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634048134 |
| Manufacturer G1 | UROLOGIX, INC. |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGIS SYSTEM |
| Generic Name | MICROWAVE DELIVERY SYSTEM |
| Product Code | MEQ |
| Date Received | 2014-02-18 |
| Returned To Mfg | 2014-01-23 |
| Model Number | 410092-001 |
| Catalog Number | 410092-001 |
| Lot Number | 130815MCA2 |
| Device Expiration Date | 2015-08-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, INC |
| Manufacturer Address | 14405 21ST AVENUE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-18 |